MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE?; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	H74939186402210
Medical Device Problem Codes	Material Rupture (1546); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon ruptured, markers detached, and additional intervention was performed.A 4.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilation.During the procedure, the balloon ruptured.While removing the balloon, both radiopaque (ro) markers detached from the catheter.One ro marker went into a side branch of the superficial femoral artery (sfa) and could not be retrieved with a snare.The other ro marker went down to the popliteal artery where it was subsequently confined using a stent.The procedure was completed using the original device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Detailed product information was not provided to boston scientific.The lot number was asked by the initial reporter but was unknown by the account/customer.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Detailed product information was not provided to boston scientific.The lot number was asked by the initial reporter but was unknown by the account/customer.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the balloon ruptured, markers detached, and additional intervention was performed.A 4.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilation.During the procedure, the balloon ruptured.While removing the balloon, both radiopaque (ro) markers detached from the catheter.One ro marker went into a side branch of the superficial femoral artery (sfa) and could not be retrieved with a snare.The other ro marker went down to the popliteal artery where it was subsequently confined using a stent.The procedure was completed using the original device.There were no patient complications as a result of this event.It was further reported that the target lesion was very calcified, hard lesion throughout the sfa, described by the physician as "coral reef".The rated burst pressure was reported at 14 atm.The physician was unable to cannulate the tiny branch to retrieve the first marker, but the vessel was so small they are not worried about it causing any complications.The other marker will stay in place since a stent was placed to confine it.The patient was stable and doing well after the procedure.

• Brand Name: COYOTE?
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21825706
• Report Number: 2124215-2025-22617
• Device Sequence Number: 11814923
• Product Code: DQY
• UDI-Device Identifier: 08714729796671
• UDI-Public: (01)08714729796671
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939186402210
• Device Catalogue Number: H74939186402210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 05/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: Black Or African American